Home GUDID 10194717110521 Regard™
Primary DI 10194717110521
Brand Regard™
Company ROI CPS, LLC
Model ET01135
Device description DENTAL
Published 2021-05-03
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name OFX General Purpose Dental Tray
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OFX General Purpose Dental Tray Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20194717110528 Package GS1 7 Not in Commercial Distribution 10194717110521 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20194717110528 20194717110528 10194717110521 10194717110521
GMDN Terms# Term, Definition table Term Definition Dental/maxillofacial surgical procedure kit, non-medicated, single-use A collection of various sterile dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.
Regulatory Flags# DUNS number 117174678 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10198956464223 CARDINAL HEALTH Cardinal Health 200, LLC OFX 2026-06-05 08720892104809 Crown Cassette 200 Rademaker Medical Instruments B.V. OFX 2026-06-04 08720892104823 Crown Cassette 100 Rademaker Medical Instruments B.V. OFX 2026-06-04 08720892104847 Crown Cassette 300 Rademaker Medical Instruments B.V. OFX 2026-06-04 08720892104861 Crown Cassette 400 Rademaker Medical Instruments B.V. OFX 2026-06-04 10198956480858 CARDINAL HEALTH Cardinal Health 200, LLC OFX 2026-06-01 10195327485092 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OFX 2024-07-29 10195327587352 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OFX 2024-07-29 10195327587444 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OFX 2024-07-29 10195327593520 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OFX 2024-07-29 10195327608170 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OFX 2024-07-29 10195327628604 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OFX 2024-07-29 10195327654252 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OFX 2024-07-29 10195327671099 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OFX 2024-07-29 10195327671136 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OFX 2024-07-29 10195327674175 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OFX 2024-04-07 10195327640170 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OFX 2024-03-03 10195327643713 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OFX 2024-03-03 10195327640408 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OFX 2024-02-25 10195327641399 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OFX 2024-02-25 10195327619978 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OFX 2024-02-11 10195327588168 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OFX 2024-01-07 10195327592608 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OFX 2024-01-07 10195327582005 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OFX 2023-12-31 10195327580599 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OFX 2023-12-24 10195327467067 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OFX 2023-12-21 10195327469184 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OFX 2023-12-21 10195327469306 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OFX 2023-12-21 10195327489366 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OFX 2023-12-21 10195327493417 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OFX 2023-12-21